DEXTROAMPHETAMINE SULFATE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)

Tersedia dari:

Zydus Pharmaceuticals (USA) Inc.

INN (Nama Internasional):

DEXTROAMPHETAMINE SULFATE

Komposisi:

DEXTROAMPHETAMINE SULFATE 5 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Dextroamphetamine Sulfate Tablets USP are indicated for: - Narcolepsy . - Attention Deficit Disorder with Hyperactivity , as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympath

Ringkasan produk:

HOW SUPPLIED Dextroamphetamine Sulfate Tablets USP are available as: 5 mg: Peach, round, flat-faced, bevel edged, scored tablet, debossed "N" score "941" on one side and plain on the other side. NDC 68382-941-01……….Bottles of 100 Tablets 10 mg: Pink, round, flat-faced, bevel edged, scored tablet, debossed "N" score "942" on one side and plain on the other side. NDC 68382-942-01……….Bottles of 100 Tablets Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. DEA Order Form Required. Manufactured By: Nesher Pharmaceuticals USA LLC St. Louis, MO 63044 Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 P10138-4                                                                                                                  12/2021

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

DEXTROAMPHETAMINE SULFATE- dextroamphetamine sulfate tablet
Zydus Pharmaceuticals (USA) Inc.
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MEDICATION GUIDE
DEXTROAMPHETAMINE SULFATE TABLETS USP, CII
(DEX-troe-am-FET-uh-meen SULL-fate)
Read the Medication Guide that comes with Dextroamphetamine Sulfate
Tablets before you or your child
starts taking them and each time you get a refill. There may be new
information. This Medication Guide does
not take the place of talking to your doctor about you or your child's
treatment with Dextroamphetamine
Sulfate Tablets.
What is the most important information I should know about
Dextroamphetamine Sulfate Tablets?
The following have been reported with use of Dextroamphetamine Sulfate
Tablets and other stimulant
medicines.
1. Heart-related problems:
•
sudden death in patients who have heart problems or heart defects
•
stroke and heart attack in adults
•
increased blood pressure and heart rate
Tell your doctor if you or your child have any heart problems, heart
defects, high blood pressure, or a family
history of these problems.
Your doctor should check you or your child carefully for heart
problems before starting Dextroamphetamine
Sulfate Tablets.
Your doctor should check your or your child's blood pressure and heart
rate regularly during treatment with
Dextroamphetamine Sulfate Tablets.
Call your doctor right away if you or your child has any signs of
heart problems such as chest pain, shortness
of breath, or fainting while taking Dextroamphetamine Sulfate Tablets.
2. Mental (Psychiatric) problems:
All Patients
•
new or worse behavior and thought problems
•
new or worse bipolar illness
•
new or worse aggressive behavior or hostility
Children and Teenagers
•
new psychotic symptoms (such as hearing voices, believing things that
are not true, are suspicious)
or new manic symptoms
Tell your doctor about any mental problems you or your child have, or
about a family history of suicide,
bipolar illness, or depression.
Call your doctor right away if you or your child have any new or
worsening mental symp

Karakteristik produk

DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE TABLET
ZYDUS PHARMACEUTICALS (USA) INC.
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DEXTROAMPHETAMINE SULFATE - DEXTROAMPHETAMINE SULFATE TABLET
CII
RX ONLY
WARNING
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION
OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO
DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION
SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING
AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO
OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED
SPARINGLY.
MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS
CARDIOVASCULAR ADVERSE EVENTS.
DESCRIPTION
Dextroamphetamine sulfate, USP is the dextro isomer of the compound
_d,l_-
amphetamine sulfate, a sympathomimetic amine of the amphetamine group.
Chemically,
dextroamphetamine is _d_-alpha-methylphenethylamine, and is present in
all forms of
dextroamphetamine sulfate, USP as the neutral sulfate. The structural
formula is as
follows:
(C9H13N)2∙H2SO4 M.W. 368.49
INACTIVE INGREDIENTS
Calcium sulfate, colloidal silicon dioxide, compressible sugar, corn
starch, magnesium
stearate, and microcrystalline cellulose.
The 5 mg also contains D&C yellow no. 10 aluminum lake and FD&C red
no. 40 aluminum
lake.
The 10 mg also contains FD&C red no. 40 aluminum lake and FD&C yellow
no. 6
aluminum lake.
CLINICAL PHARMACOLOGY
Amphetamines are non-catecholamine, sympathomimetic amines with CNS
stimulant
activity. Peripheral actions include elevations of systolic and
diastolic blood pressures
and weak bronchodilator and respiratory stimulant action.
There is neither specific evidence which clearly establishes the
mechanism whereby
amphetamines produce mental and behavioral effects in children, nor
conclusive
evidence regarding how these effects relate to the condition of the
central nervous
system.
PHARMACOKINETICS
The pharmacokinetics of the tablet and sustained-release capsule were
compared in 12
healthy subjects. The extent of bioavailability of the
sustained-release capsule was similar
compared to t